Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty:
Primary Purpose
Low-level Laser Acupuncture in Patients With Total Knee Arthroplasty
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
low-level laser
Sham laser
Sponsored by
About this trial
This is an interventional treatment trial for Low-level Laser Acupuncture in Patients With Total Knee Arthroplasty focused on measuring Acupuncture points, low-level laser, postoperative pain, total knee arthroplasty
Eligibility Criteria
Inclusion Criteria:
- age 60 years or older
- American Sociological Association (ASA) class I-III
- spinal anesthesia, consent to patient-controlled analgesia (PCA) and peripheral nerve block (PNB)
- return to the ward directly from the anesthesia recovery room.
Exclusion Criteria:
- cutaneous lesions at the application sites
- use of taking immunosuppressive agents
- received intra-articular steroid treatment
- opiate dependence
- sensitive to light
- epilepsy
- clinically significant cardiovascular diseases
- cancer
- systemic lupus erythematosus.
Sites / Locations
- Taipei Veteran General Hospital : Taipei City, Taiwan 11217, R.O.C.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
low-level laser therapy
Sham laser acupuncture treatment
Arm Description
808nM wavelength, power density of 300mW
received the same manner except for joule.
Outcomes
Primary Outcome Measures
The Numerical Rating Scale (NRS)
NRS was assessed pain intensity, ranging from 0 (no pain) to 10 (worst pain imaginable).higher scores, higher pain.
Brief Pain Inventory (BPI)
The patients answered or pointed their pain on 0-to-10 scales (0=no pain, 10=extreme pain) at the time of responding to the BPI(current pain), and also at the items of "the most severe pain", "the least pain", and "the average pain" in the last 24 hours. Using the BPI, patients were also asked to rate pain-related interference in daily activities, including general activity, mood, walking ability, normal work, relations with other people, sleeping, and enjoyment of life. The anchor points, in each items of interference scale, were 11-point NRSs (0=no interference, 10=interferes completely).
Secondary Outcome Measures
Full Information
NCT ID
NCT03995446
First Posted
May 19, 2019
Last Updated
June 21, 2019
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT03995446
Brief Title
Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty:
Official Title
Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
April 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Total knee arthroplasty is a common and effective surgical procedure for patients with end-stage knee osteoarthritis, and wound pain is still a problem for many of the patients.
Detailed Description
Therefore, the purpose of this study was to apply low level laser therapy Measured variables included postoperative pain intensity, patient-controlled analgesia requirements, side effects caused by morphine, knee stiffness and wound pain in the daily activities of patients undergoing total knee arthroplasty. Data were collected between April 2018 and January 2019. Eighty-two knee osteoarthritis patients receiving total knee arthroplasty were recruited from one hospital and randomly, equally assigned to the laser acupuncture or control group. The LA group received the low-level laser therapy with 3 joules at each acupuncture point at Hour 2, Hour 6, Hour 10, Hour 24, Hour 48, and Hour 72 after surgery; whereas the control group received the same manner except for joule.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-level Laser Acupuncture in Patients With Total Knee Arthroplasty
Keywords
Acupuncture points, low-level laser, postoperative pain, total knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low-level laser therapy
Arm Type
Experimental
Arm Description
808nM wavelength, power density of 300mW
Arm Title
Sham laser acupuncture treatment
Arm Type
Sham Comparator
Arm Description
received the same manner except for joule.
Intervention Type
Device
Intervention Name(s)
low-level laser
Intervention Description
low level laser emission on specific acupuncture points
Intervention Type
Device
Intervention Name(s)
Sham laser
Intervention Description
Sham laser
Primary Outcome Measure Information:
Title
The Numerical Rating Scale (NRS)
Description
NRS was assessed pain intensity, ranging from 0 (no pain) to 10 (worst pain imaginable).higher scores, higher pain.
Time Frame
the first 72 hours after the surgery
Title
Brief Pain Inventory (BPI)
Description
The patients answered or pointed their pain on 0-to-10 scales (0=no pain, 10=extreme pain) at the time of responding to the BPI(current pain), and also at the items of "the most severe pain", "the least pain", and "the average pain" in the last 24 hours. Using the BPI, patients were also asked to rate pain-related interference in daily activities, including general activity, mood, walking ability, normal work, relations with other people, sleeping, and enjoyment of life. The anchor points, in each items of interference scale, were 11-point NRSs (0=no interference, 10=interferes completely).
Time Frame
the first 72 hours after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 60 years or older
American Sociological Association (ASA) class I-III
spinal anesthesia, consent to patient-controlled analgesia (PCA) and peripheral nerve block (PNB)
return to the ward directly from the anesthesia recovery room.
Exclusion Criteria:
cutaneous lesions at the application sites
use of taking immunosuppressive agents
received intra-articular steroid treatment
opiate dependence
sensitive to light
epilepsy
clinically significant cardiovascular diseases
cancer
systemic lupus erythematosus.
Facility Information:
Facility Name
Taipei Veteran General Hospital : Taipei City, Taiwan 11217, R.O.C.
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35459599
Citation
Huang CH, Yeh ML, Chen FP, Wu D. Low-level laser acupuncture reduces postoperative pain and morphine consumption in older patients with total knee arthroplasty: A randomized placebo-controlled trial. J Integr Med. 2022 Jul;20(4):321-328. doi: 10.1016/j.joim.2022.04.002. Epub 2022 Apr 9.
Results Reference
derived
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Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty:
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